CSV Analyst

Overview

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here.

For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing services and automation. With our industry-specific platforms, we deliver continuous value addition, and innovation that will improve your business outcomes. Outsourcing is not just a method of gaining a one-time cost advantage, but an effective strategy for gaining and maintaining competitive advantages when executed as part of an overall sourcing strategy.

NTT DATA's Client is seeking a detail-oriented and experienced Computer System Validation (CSV) Analyst to ensure that GxP-regulated computerized systems (IT, laboratory, and manufacturing systems) operate accurately, reliably, and in compliance with regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines in Puerto Rico.

The candidate will be responsible for maintaining systems in a validated state through risk‑based validation approaches, lifecycle documentation, and audit readiness activities.

Location:

Juncos, Puerto Rico

• Validation Documentation & Protocol Development – Author, review, and approve Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), and Validation Summary Reports.
• Develop and execute validation protocols including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Ensure all documentation complies with GxP and regulatory requirements.
• Testing & Execution – Perform and document IQ/OQ/PQ activities; coordinate with cross‑functional teams to ensure timely execution of validation deliverables; document and manage deviations observed during testing.
• Compliance & Risk Management – Ensure adherence to FDA 21 CFR Part 11, EU Annex 11, data integrity principles, and GAMP 5 methodology; conduct risk assessments to determine the appropriate level of validation; support periodic reviews and validation lifecycle maintenance.
• Lifecycle & Change Management – Manage change control processes for validated systems; support CAPA (Corrective and Preventive Action) activities; ensure systems remain in a validated state throughout their lifecycle.
• Audit & Inspection Support – Participate in internal and external audits and regulatory inspections; provide validation documentation and compliance evidence during audits.

• Bachelor's degree in Computer Science, Life Sciences, Engineering, or a related field.
• 3–8 years of hands‑on experience in Computer System Validation (CSV) within FDA‑regulated industries (Pharmaceuticals, Biotechnology, or Medical Devices).
• 3–8 years of strong understanding of GAMP 5 methodology, Software Development Life Cycle (SDLC), data integrity principles, and FDA 21 CFR Part 11 and EU Annex 11.
• Spanish language proficiency (reading, writing, and speaking) is mandatory.

• 3 years of experience with laboratory systems (LIMS), ERP, MES, or Quality Management Systems.
• Strong documentation and communication skills.
• Ability to work in cross‑functional, global teams.
• Knowledge of risk‑based validation approaches.

NTT DATA Services is a recognized leader in IT and business services, including cloud, data and applications, headquartered in Texas. As part of NTT DATA, a $30 billion trusted global innovator with a combined global reach of over 80 countries, we help clients transform through business and technology consulting, industry and digital solutions, applications development and management, managed edge‑to‑cloud infrastructure services, BPO, systems integration, and global data centers.

We are committed to our clients' long‑term success. Visit  or Linked In to learn more.

NTT DATA Services is an equal opportunity…